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More bad news I'm afraid.

Harry

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Second Patient Who Used MS Drug Dies
March 04, 2005 6:01 AM EST
DUBLIN, Ireland - A second patient taking a recently suspended multiple sclerosis-fighting drug, Tysabri, has died from a rare disease, the Irish and American companies who developed the highly touted medication said Friday.

Elan Corp. of Ireland and Biogen Idec Inc. of Cambridge, Mass., had announced Monday that they were withdrawing Tysabri because one patient had died of progressive multifocal leukoencephalopathy, a usually fatal disease of the central nervous system, while a second patient had also developed PML.

The two companies confirmed Friday that the second patient had also died.

Tysabri had been approved in November by the U.S. Food and Drug Administration following promising clinical trials that demonstrated the drug's ability to prevent relapses in many MS sufferers.

The drug was being used by about 3,000 MS sufferers in the United States and 22 people in Ireland before its withdrawal from the market. Tysabri was also withdrawn from clinical trials on sufferers of Crohn's disease and rheumatoid arthritis.

Both patients who died were taking Tysabri with Avonex, an older MS-fighting drug developed by Biogen Idec. It has remained on the market.

The companies stressed in a joint statement that, for now, there was no evidence that either drug taken on its own was linked to PML.

"To date, the companies have received no reports of PML in patients receiving Tysabri monotherapy for MS or in patients with Crohn's disease or rheumatoid arthritis," the companies said. "Biogen Idec has not received any reports of PML in patients treated with Avonex alone, a product on the market since 1996."

The companies also confirmed they both were providing unspecified new information to the U.S. Securities and Exchange Commission, which spent two years investigating accounting malpractice at Elan. The Irish company last month paid $15 million to the SEC to settle the probe.

In the wake of Tysabri's withdrawal, senior figures at Biogen Idec have admitted they sold large volumes of their company's shares in the week before the announcement but have denied any wrongdoing.

Shares in both Elan and Biogen Idec have been hammered this week, losing more than half their value. Ian Hunter, an analyst at Goodbody Stockbrokers in Dublin, said confirmation of the second death would put more pressure on the companies' market values.

Elan's shares in Dublin fell 60 euro cents (79 cents) in early Friday trading to 4.97 euros ($6.55). Last Friday, before the Tysabri announcement, its shares closed at 20.30 euros ($26.60).

Earlier this week Elan Chief Executive Kelly Martin insisted that the company was hopeful of reintroducing Tysabri - Elan's key drug - to the market later this year.

Oh yes, that was WAY out of line!!!!

What about odd duck implying that others enjoy participating in criminal activity? Hmmm.

And if saying that odd duck was fussy was soooo out of line, why wasn't it edited?
OK, I'd like to stop this grade school bickering here.

BTW, saying that Tysabri was fast tracked could have prevented these problems, did you stop to think that these people still would have contracted PML? Do you think that clinical trials should be stopped indefinitely? I mean after all, that's the only way to prevent anything like this from happening, correct?

The way I see it, this is the only way we will ever make advances in medicine. It's a shame that people die, I know this, but something has to be done for the greater good.

They did voluntarily suspend it. Correct? AND the final say so was left up to the FDA.

Also, did you see that the second person with PML, has NOT died? That story was retracted.

coolycat wrote:....Also, did you see that the second person with PML, has NOT died? That story was retracted.

What specifically is your source for this information?

Below is my source for info on the 2nd death.

http://www.forbes.com/work/feeds/ap/200 ... 62899.html

flora68 wrote:coolycat, if you're still around...

I know a lot of other people feel the same way you do about Tysabri looking so promising, and then being taken away as suddenly as it was released. Angry, frustrated, despondent, suspicious, in denial, whatever; there are a lot of bad feelings. Regardless, they're your feelings and you're entitled to them.

But you're venting them in the wrong direction, kid. Harry didn't do anything to anybody, nor did Deb. They just figured it out before you did, that's all .

However, you are right about one thing ; most people in the trials did report significant improvement on Tysabri, as did many who started on it after FDA approval. No doubt about that part. And it's also true that "only" 2 people in the trials died from it so far, out of almost 3,000.

And to someone who obviously knows (and cares) little or nothing about things like scientific method, drug trial protocols, the immune system, and the many other decidedly un-sexy facts and details of this situation like JCV and PML, those figures may sound like acceptable odds. Sounds like "only" 2 people died, out of almost 3,000 "helped", right?

Wrong.

Because they weren't finished yet! (Speaking of which, why, precisely, do you "find it unlikely" that there would have been any more deaths if they hadn't suspended use of Tysabri?)

You can't tell how further Tysabri use would have worked out any more than you can tell by the number of characters alive at Intermission how many will still be on their feet by the end of the last act.

More importantly, no medication can be considered a success if the patients start dying off after only two years of trials.....

There's no reason to assume that the improvement seen with Tysabri would or wouldn't have continued indefinitely, particularly without harm to the patient. I can tell you that leaving one's brain totally defenseless against things like meningitis or encephalitis isn't going to remain anyone's answer for long.

No, coolycat, people with immune systems don't just up and die from the JCVirus.

And there are important reasons why drug trials are supposed to last longer than Tsaybri's did before unleashing it upon the masses, no matter how impatient people are to cut to the punch line.

A bit of advice: If you're really hoping to hold your own in this particular "discussion" with two MS-research heavyweights like Harry and Deb as opponents, do yourself a favor and actually do some reading first. The last article pasted would be a good place to start.

Flora,
Please look back at my original post, I was not venting. My goodness, I didn't realize how personal some folks take things here.

BTW, there have not been 2 deaths.....there has been one.

It's statements like that, that upset me.

Also, Harry didn't "figure" it out. He was merely repeating what he was told from an inaccurate source.

AND I would never classify he or Deb as a heavyweight when it comes to medical research.

I do not appreciate being talked down to.

flora68 wrote:

coolycat wrote:....Also, did you see that the second person with PML, has NOT died? That story was retracted.

What specifically is your source for this information?

Below is my source for info on the 2nd death.

http://www.forbes.com/work/feeds/ap/200 ... 62899.html

http://biz.yahoo.com/ap/050304/ireland_ ... ive_3.html


Associated Press
Correction: AP Corrects Story on Tysabri
Friday March 4, 11:08 am ET Correction: AP Corrects Story on Suspended Drug Tysabri

DUBLIN, Ireland (AP) -- In a story earlier Friday, The Associated Press erroneously reported that a patient had died in a second confirmed case of a rare nerve disease after taking the recently suspended multiple sclerosis-fighting drug, Tysabri. While a first case was fatal, the second patient to contract the disease is still alive. The AP has transmitted a corrected version of this story.

Elan Corp. of Ireland and Biogen Idec Inc. of Cambridge, Mass., had announced Monday that they were withdrawing the drug. On Friday, they announced the second case of the nerve disease had been confirmed.


edited to fix link

coolycat wrote:....Please look back at my original post, I was not venting. My goodness, I didn't realize how personal some folks take things here.

BTW, there have not been 2 deaths.....there has been one.

It's statements like that, that upset me.

Also, Harry didn't "figure" it out. He was merely repeating what he was told from an inaccurate source.

AND I would never classify he or Deb as a heavyweight when it comes to medical research.

I do not appreciate being talked down to.

coolycat,

First, about the Tysabri death toll being 1 and not 2...when you get down to it, what's the difference?!...between 2 patients being completely, actually dead from PML, and the amended version....only one actually dead and the other one almost-but-not-quite-dead?

As I understand it, that 2nd patient's diagnosis hasn't been retracted, so he or she does have PML, and will die from it soon. So why do "statements like that upset" you? Do you really feel safer knowing that patient #2 hasn't quite finished dying yet?

Second, I was looking at your first post, in which you now claim you weren't venting. Does that mean that you always talk to people like that?

Your first post accused some very well-intentioned, hard-working, highly valued members of this forum, who almost daily provide us with a wealth of well-researched information (with sources) and support, of not only floating "rumors" around and "scaring people needlessly", but of "playing doctor or super nurse on the internet".

My goodness, I didn't realize how personal some folks take things here.

Can't imagine why anyone would take offense at that, huh?

And as for that wonderful last statement you made, "I do not appreciate being talked down to".

...coolycat, nobody appreciates being talked down to (unless they've fallen into a well or something!), so why don't you just knock it off? Things were pretty civil around here before your oh-so-friendly first post....

Coolcat,

OK, I'd like to stop this grade school bickering here.

That's fine by me

BTW, saying that Tysabri was fast tracked could have prevented these problems, did you stop to think that these people still would have contracted PML? Do you think that clinical trials should be stopped indefinitely? I mean after all, that's the only way to prevent anything like this from happening, correct?

If Biogen had not fast-tracked Tysabri it would not have prevented these two trial patients from getting PML but it would have stopped the other 5000 patients from starting on the drug and avoided the mess that Biogen finds itself in now.....litigation included!

Nobody has ever inferred that clinical trials be stopped forever but when someone dies in a trial, the standard procedure is to stop the drug immediately and take a step back to find out what went wrong. That's exactly what happened when my wife was part of a clinical trial back in the late 90's. A new promising MS drug which stopped and reversed MS in that poor little MS mouse was being tested on humans. After about a year, a participant died from heart problems related to the drug. The trial was immediately stopped, then canceled for good. Marg was on the placebo!

The way I see it, this is the only way we will ever make advances in medicine. It's a shame that people die, I know this, but something has to be done for the greater good.

Coolycat, I think you are missing the point in this discussion. Nobody has a problem with clinical trials which are absolutely necessary. What people such as myself are concerned about is how Biogen conducted themselves with Tysabri. They ignored warnings from prominent MS docs, marketed Tysabri for months before it got FDA approval, issued press releases about how safe and excellent the drug was and did all this BEFORE the two year data started becoming available. And then two patients died!!
And we see that their execs made millions in profits by selling the day before the FDA was given the bad news about the deaths!! That's what some of us are complaining about!!!

They did voluntarily suspend it. Correct? AND the final say so was left up to the FDA.

Believe me, had they not "voluntarily" suspended Tysabri, the FDA would have forced them to. It's just a lot less paperwork involved when it's done this way.

Also, did you see that the second person with PML, has NOT died? That story was retracted.

The second PML patient unfortunately is going to die since the disease is always fatal.
Harry

Harry,The second patient did die or so I read this morning. As far as the death rate from PML, there was an article in the Boston Globe yesterday where they talked with the top PML expert in the country. He said they've got the death rate down to about 50%.

Peter

50%... interesting! There is (also) apparently a 10% spontaneous recovery rate:

"PML is almost always progressive and fatal. Death usually occurs between one and four months after the first symptoms appear. However, there have been a number of reported cases with survival ranging from several months to years. What's more, up to 10% of people with PML spontaneously recover, either with or without treatment."

That's from http://www.aidsmeds.com

Anyways, I'm stepping in here before this gets (further) out of hand. I believe you have all made your points and now it's going in circles and getting personal.

This thread is now locked, thank you all for your contributions to it.